100 Participants Needed

Acoustic + Electrical Stimulation for Tinnitus

SG
HD
Overseen ByHamid Djalilian, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing if playing sounds through headphones or using small electrical currents in the ear can help people with tinnitus. It targets those whose tinnitus significantly affects their quality of life. The treatment works by trying to interfere with the ringing noise, making it quieter or stopping it. Using small electrical currents has been explored in various studies as a potential treatment for tinnitus, showing mixed results in terms of effectiveness.

Do I need to stop taking my current medications for the trial?

If you are taking medications known to cause tinnitus, like aspirin, ibuprofen, or naproxen, you must be able to stop them to participate in the trial. Otherwise, the protocol does not specify if you need to stop other medications.

Is acoustic and electrical stimulation therapy safe for humans?

Research indicates that electrical stimulation for tinnitus is generally safe when used within recommended guidelines, although a small number of patients may experience temporary or permanent increases in tinnitus.12345

How does the Acoustic + Electrical Stimulation treatment for tinnitus differ from other treatments?

The Acoustic + Electrical Stimulation treatment for tinnitus is unique because it combines sound therapy with transcutaneous electrical nerve stimulation (TENS), which involves sending mild electrical currents through the skin to help reduce tinnitus symptoms. This approach is different from other treatments as it targets both auditory and nerve pathways, potentially offering relief for patients with specific types of tinnitus, such as those with low-frequency tinnitus and mild hearing loss.34678

What data supports the effectiveness of the treatment Acoustic + Electrical Stimulation for Tinnitus?

Research shows that transcutaneous electrical stimulation (TENS) can help reduce tinnitus symptoms in some patients, with about half experiencing improvement and a third seeing substantial benefits. This suggests that the combination of acoustic and electrical stimulation might also be effective for tinnitus relief.346910

Are You a Good Fit for This Trial?

This trial is for adults who have had tinnitus, or ringing in the ears, for at least six months. Participants must speak English well enough to describe their experiences and complete surveys. Those with cochlear implants can join the electrical stimulation part of the study. Excluded are individuals under 18, pregnant or breastfeeding women, those on certain medications like aspirin that cause tinnitus, with ear abnormalities or treatable causes of tinnitus.

Inclusion Criteria

To be able to accurately describe the unusual sensations caused by electrical stimulation, and to be able to complete surveys about them.
I am either male or female.
I have a cochlear implant.
See 1 more

Exclusion Criteria

I have issues with my ear canal or ear drum.
I have a long-term ear infection.
My tinnitus can be treated.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo acoustic and electrical stimulation to evaluate tinnitus suppression

12 months
Multiple visits throughout the year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Acoustic
  • Electrical
Trial Overview The study investigates acoustic and electrical stimulation as treatments for tinnitus. Acoustic tests involve listening to sounds through headphones and rating tinnitus loudness. Electrical tests use a cochlear implant or electrodes placed in/on the ear to assess changes in tinnitus perception.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Electrical/ Acoustic stimulationExperimental Treatment2 Interventions

Acoustic is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Electrical Stimulation Therapy for:
🇪🇺
Approved in European Union as Electrical Stimulation Therapy for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials
580
Recruited
4,943,000+

Published Research Related to This Trial

In a study involving 500 patients with various causes of tinnitus, 53% experienced a reduction in their tinnitus symptoms after receiving 6 to 10 sessions of electrical stimulation treatment.
The treatment showed lasting benefits, with 72% of patients maintaining their improvement at a 3-month follow-up, although there were some cases of temporary or permanent increases in tinnitus for a few patients.
Treatment of tinnitus with electrical stimulation.Steenerson, RL., Cronin, GW.[2017]
Transcutaneous electrical stimulation (TENS) significantly alleviates tinnitus symptoms, with 62.2% of patients reporting improvement after treatment, as measured by the Tinnitus Handicap Inventory (THI) and visual analog scale (VAS).
The effectiveness of TENS is particularly notable in patients with low-frequency tinnitus and mild hearing loss, suggesting that these characteristics may predict better responses to this treatment.
Effectiveness of transcutaneous electrical stimulation for chronic tinnitus.Lee, SK., Chung, H., Chung, JH., et al.[2022]
Transcutaneous electric stimulation using square waves can lead to significant improvement in about one-third of severe tinnitus cases, with treatment sessions lasting only a few minutes.
For optimal results, this stimulation should be repeated two to three times, but if no improvement is seen after these attempts, it is unlikely to be effective, although the exact mechanism behind the improvement remains unclear.
Transcutaneous electrotherapy for severe tinnitus.Chouard, CH., Meyer, B., Maridat, D.[2019]

Citations

Treatment of tinnitus with electrical stimulation. [2017]
Effectiveness of transcutaneous electrical stimulation for chronic tinnitus. [2022]
Transcutaneous electrotherapy for severe tinnitus. [2019]
[Treatment of tinnitus by mean of electric transcutaneous stimulation (author's transl)]. [2006]
Transcutaneous Electrical Nerve Stimulation for Treatment of Tinnitus: A Systematic Review and Meta-analysis. [2021]
Tinnitus reduction using transcutaneous electrical stimulation. [2019]
The effect of transcutaneous electrical nerve stimulation (TENS) on chronic subjective tinnitus. [2020]
Treatment of tinnitus with transcutaneous electrical nerve stimulation improves patients' quality of life. [2008]
Transcutaneous Electric Nerve Stimulation in Chronic Subjective Tinnitus. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
External electrical tinnitus suppression: a review. [2006]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security